Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms (LUTS)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01457573
First received: October 20, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

A single center, pilot trial with combination therapy of tamsulosin and solifenacin in 20 men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes.


Condition Intervention
Lower Urinary Tract Symptoms
Drug: Solifenacin (Vesicare) 5 mg orally at the same time.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • NGF and NGF/Cr ratio-change [ Time Frame: From baseline to week 12 (3 months) ] [ Designated as safety issue: Yes ]
    Urinary Nerve Growth Factor (NGF) and NGF/Cr ratio-change from baseline to week 12.


Secondary Outcome Measures:
  • Quality of Life Questionnaires [ Time Frame: Baseline to weeks 4 and 8. ] [ Designated as safety issue: Yes ]
    International Prostate Symptom Score, Patient Perception of Urgency Score (PPIUS), Perception of Bladder Condition (PBC), International Consultation on Incontinence Modular Questionnaire for male LUTS (ICIQ-MLUTS) and the International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life (ICIQ-LUTSqol).


Enrollment: 20
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamsulosin 0.4 mg + Solifenacin 5 mg
All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.
Drug: Solifenacin (Vesicare) 5 mg orally at the same time.

Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg

All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men > 50 years old with symptomatic LUTS (clinical BPH)
  • IPSS > 8
  • PSA < 10 (negative biopsies within 6 months for any age-specific PSA elevation suspicious for prostate carcinoma)
  • Post void residual urine < 150 mls
  • Urinary Flow rate > 15 mL/sec

Exclusion Criteria:

  • Neurogenic bladder
  • Urinary tract infection, Urinary stone(s), Urinary tract tumor
  • Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic, colon, rectum, prostate, bladder, uterus or ovaries
  • Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha reductase therapy within 18 months.
  • History of cataracts with planned surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457573

Locations
United States, Texas
The Methodist Hospital System
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Timothy Boone, M.D. The Methodist Hospital System
  More Information

No publications provided

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01457573     History of Changes
Other Study ID Numbers: IRB# 0711-0124
Study First Received: October 20, 2011
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mitogens
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 26, 2014